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The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

This study has been completed.
Novo Nordisk A/S
Information provided by:
Genesys Identifier:
First received: January 26, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Condition Intervention
Sepsis Respiratory Failure Renal Failure Surgical Site Infection Drug: Novolin R (human recombinant Insulin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.

Resource links provided by NLM:

Further study details as provided by Genesys:

Primary Outcome Measures:
  • Mortality

Secondary Outcome Measures:
  • Length of ICU Stay
  • Ventilatory Requirement
  • Vasopressor Support
  • Incidence of Renal Failure
  • Incidence of Wound Infection

Estimated Enrollment: 317
Study Start Date: July 2003
Estimated Study Completion Date: October 2005
Detailed Description:
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability

Exclusion Criteria:

  • Under age 18
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Please refer to this study by its identifier: NCT00282594

United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Novo Nordisk A/S
Principal Investigator: Michael Kia, DO Genesys Regional Medical Center
  More Information

Publications: Identifier: NCT00282594     History of Changes
Other Study ID Numbers: GRMC 050023
Study First Received: January 26, 2006
Last Updated: January 26, 2006

Keywords provided by Genesys:
Intensive Insulin Therapy
General Surgical
Vascular Surgical
Tight Glycemic Control

Additional relevant MeSH terms:
Renal Insufficiency
Respiratory Insufficiency
Surgical Wound Infection
Kidney Diseases
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on July 28, 2017